- |||||||||| Zubsolv (buprenorphine/naloxone sublingual tablet) / Orexo, Mundipharma, Vivitrol (naltrexone extended-release injectable suspension) / Alkermes, Sublocade (buprenorphine once-monthly depot) / Indivior
Journal: Comparison table: Some drugs for maintenance treatment of opioid use disorder. (Pubmed Central) - Aug 31, 2023
Initiation date: Aug 2024 --> Nov 2024 No abstract available
- |||||||||| Sublocade (buprenorphine once-monthly depot) / Indivior
Review, Journal: Buprenorphine and its formulations: a comprehensive review. (Pubmed Central) - Aug 25, 2022
Lastly, in order to avoid misuse of buprenorphine for opioid dependence, two combination formulations paired with naloxone were developed: film formulation (Suboxone®) and tablet formulation (Zubsolv®). In this review, we present details of each formulation along with their similarities and differences between each other and clinical considerations.
- |||||||||| Zubsolv (buprenorphine/naloxone sublingual tablet) / Orexo, Mundipharma
Mu-Opioid Receptor Epigenetics in Persons With Opioid Use Disorder: A Pilot Study (Symphony Ballroom III) - Jun 1, 2022 - Abstract #CPDD2022CPDD_331;
Nine of these participants completed a within-subject crossover study, starting with 2 days of oral morphine stabilization (tailored to pre-experimental opioid use; range, 30 ¢â‚¬â€œ75 mg TID), followed by randomized, blinded exposure for 2 weeks each to low, moderate, and high daily doses of sublingual B/N (1.4/0.36, 4.2/1.08, and 12.8/3.2 mg Zubsolv ¢â€žÂ¢) and provided epigenetic and symptom data in each medication condition. Although sample size is small, these preliminary data suggest µ-receptor DNA methylation appears related to age (senescence clock), current heroin use, and parental divorce/separation (but not other early-life stressors), whereas short-term stabilization on different doses of B/N does not affect µ-receptor methylation.
- |||||||||| Zubsolv (buprenorphine/naloxone sublingual tablet) / Orexo, Mundipharma
Journal: Characterization of Buprenorphine Antagonism at Human Mu Opioid Receptors. (Pubmed Central) - May 14, 2022
One such medication is buprenorphine, an FDA approved drug for the treatment of opioid use disorder sold under the brand Suboxone®, Subutex®, and Zubsolv®...Similar antagonism by buprenorphine was observed when fentanyl was used as the MOR agonist...These kinetics were further supported in high-expressing hMOR CHO cells, as buprenorphine agonism was resistant to reversal by naloxone or washing. As a frontline treatment for opioid use disorder, an understanding of buprenorphine's pseudo-irreversible binding may elucidate buprenorphine's unique properties and facilitate future drug discovery.
- |||||||||| Zubsolv (buprenorphine/naloxone sublingual tablet) / Orexo, Mundipharma
Trial completion: Assessing the Safety of Buprenorphine in People With Sickle Cell Disease (clinicaltrials.gov) - Apr 25, 2022
P2, N=47, Completed,
As a frontline treatment for opioid use disorder, an understanding of buprenorphine's pseudo-irreversible binding may elucidate buprenorphine's unique properties and facilitate future drug discovery. Active, not recruiting --> Completed
- |||||||||| Sublocade (buprenorphine once-monthly depot) / Indivior
Trial completion, Trial completion date: XRB vs. SLB in Jail and at Re-entry: Pilot, Proof of Concept (clinicaltrials.gov) - Mar 12, 2021
P4, N=52, Completed,
However, we did not examine a causal association between these variables. Recruiting --> Completed | Trial completion date: Sep 2020 --> May 2020
- |||||||||| Zubsolv (buprenorphine/naloxone sublingual tablet) / Orexo, Mundipharma, buprenorphine/naloxone sublingual tablet / Aoxing, Suboxone (buprenorphine/naloxone sublingual film) / Indivior
[VIRTUAL] Assessment of Opioid Withdrawal with Clinical Opiate Withdrawal Scale Treatment Protocol at A Community Psychiatric Hospital () - Dec 26, 2020 - Abstract #ASHP2020ASHP_2500;
In the interim analysis, only a small percentage of patients were assessed with the COWS protocol at the frequency as indicated by the opioid withdrawal order set. This demonstrates the need to re-evaluate optimal dosing strategies in opioid use disorder patients or education on the use of the COWS protocol.
- |||||||||| Zubsolv (buprenorphine/naloxone sublingual tablet) / Orexo, Mundipharma, Suboxone (buprenorphine/naloxone sublingual film) / Indivior
[VIRTUAL] Opioid-Use Related Adverse Drug Effects in Surgical Patients on Long-Acting Opioids Prior to Admission () - Dec 26, 2020 - Abstract #ASHP2020ASHP_1566;
Concomitant use of long-acting and short-acting opioids prior to hospital admission for an elective surgical procedure, female gender, and hospital length of stay were the strongest predictors of increased risk of developing PONV and pruritus. Future work can look into pharmacist-led services for opioid management through preoperative interventions in determining the opiate need for patients at hospital admission, in particular with patients on multiple opioid formulations, for further reduction of adverse events in their continuum of care.
- |||||||||| Zubsolv (buprenorphine/naloxone sublingual tablet) / Orexo, Mundipharma
[VIRTUAL] Development and implementation of a naloxone co-dispensing protocol for patients receiving orthopedic surgery () - Dec 26, 2020 - Abstract #ASHP2020ASHP_1052;
Patients who receive either a total hip or knee arthroplasty at LMH Health during the study period will be screened for OIRD using the following criteria: currently taking benzodiazepines or other medicines that depress the central nervous system, history of opioid use disorder (OUD), previous opioid overdose, presence of household members at risk for accidental opioid ingestion or overdose, prescribed oral morphine equivalents (OME) greater than 50 mg/day and/or long-acting opioid, and current prescription for buprenorphine or methadone to treat OUD...Primary endpoints include rate of naloxone recommendation after screening and patient acceptance of naloxone after counseling. Secondary outcomes could include patient cost, OME prescribed on discharge, and risk factors identified in this patient population.
- |||||||||| Zubsolv (buprenorphine/naloxone sublingual tablet) / Orexo, Mundipharma, Suboxone (buprenorphine/naloxone sublingual film) / Indivior
Clinical, Journal: Transitioning a patient from injectable opioid agonist therapy to sublingual buprenorphine/naloxone for the treatment of opioid use disorder using a microdosing approach. (Pubmed Central) - Dec 23, 2020
Recent Canadian guidelines suggest the use of alternate therapies, including slow-release oral morphine or injectable opioid agonist therapy (iOAT) for individuals unsuccessful with either methadone or buprenorphine/naloxone...Literature addressing how best to accomplish this, however, is currently lacking. Accordingly, the case presented here describes a patient that successfully transitions from iOAT to oral buprenorphine/naloxone using a novel induction approach termed microdosing.
- |||||||||| Sublocade (buprenorphine once-monthly depot) / Indivior
Enrollment change: SUBLOCADE Rapid Initiation Study (clinicaltrials.gov) - Dec 9, 2020
P4, N=26, Completed,
Accordingly, the case presented here describes a patient that successfully transitions from iOAT to oral buprenorphine/naloxone using a novel induction approach termed microdosing. N=49 --> 26
- |||||||||| Zubsolv (buprenorphine/naloxone sublingual tablet) / Orexo, Mundipharma
Clinical, Journal: Initiation of injectable opioid agonist treatment in hospital: A case report. (Pubmed Central) - Nov 19, 2020
We describe the case of a 47-year-old man with a severe, active opioid use disorder and daily use of illicitly manufactured fentanyl, who was re-admitted to hospital for post-operative management after leaving against medical advice due to uncontrolled opioid withdrawal. Intravenous hydromorphone was used to retain him in care, allowing for completion of his antibiotics and enrolment in ongoing community injectable opioid agonist treatment.
- |||||||||| Zubsolv (buprenorphine/naloxone sublingual tablet) / Orexo, Mundipharma
Trial completion, Phase classification, Enrollment change: BOS: Effects of Buprenorphine/Naloxone Dose on Experimental Stress Reactivity and Opioid Abstinence (clinicaltrials.gov) - Nov 10, 2020
P1/2, N=26, Completed,
Intravenous hydromorphone was used to retain him in care, allowing for completion of his antibiotics and enrolment in ongoing community injectable opioid agonist treatment. Recruiting --> Completed | Phase classification: P1 --> P1/2 | N=40 --> 26
- |||||||||| Zubsolv (buprenorphine/naloxone sublingual tablet) / Orexo, Mundipharma, Vivitrol (naltrexone extended-release injectable suspension) / Alkermes
Clinical, Journal: Attitudes toward opioid use disorder medications: Results from a U.S. national study of individuals who resolved a substance use problem. (Pubmed Central) - Nov 4, 2020
We examined the prevalence of positive, neutral, and negative attitudes toward agonists, such as buprenorphine/naloxone and methadone, and antagonists, such as oral and extended-release depot injection naltrexone...This population-level study of U.S. adults who resolved an AOD problem showed that agonist attitudes may be more positive than anecdotal evidence suggests. Certain characteristics and experiences, however, highlight a greater likelihood of negative attitudes, suggesting these factors may be potential barriers to OUD medication adoption.
- |||||||||| Zubsolv (buprenorphine/naloxone sublingual tablet) / Orexo, Mundipharma
Trial completion date: Assessing the Safety of Buprenorphine in People With Sickle Cell Disease (clinicaltrials.gov) - Oct 21, 2020
P2, N=47, Active, not recruiting,
Certain characteristics and experiences, however, highlight a greater likelihood of negative attitudes, suggesting these factors may be potential barriers to OUD medication adoption. Trial completion date: Sep 2020 --> Jun 2021
- |||||||||| Clinical, Journal: Opioid therapy in patients with liver cirrhosis (Pubmed Central) - Sep 26, 2020
In the following article, the relevant pharmacokinetic properties of the most common opioids in Switzerland and the resulting consequences regarding dose adjustment in liver cirrhosis are going to be discussed. Buprenorphine, fentanyl, hydromorphone, morphine, naloxone und tapentadol are drugs with a high first-pass effect, while the bioavailability of methadone, oxycodone and tramadol is > 70 %.
- |||||||||| fentanyl citrate / Generic mfg., Zubsolv (buprenorphine/naloxone sublingual tablet) / Orexo, Mundipharma, methadone / Generic mfg.
[VIRTUAL] Antagonists pharmacologically chaperone opioid receptors (On Demand Oral) - Aug 20, 2020 - Abstract #ACSFall2020ACS-Fall_2337;
In contrast to these effects of antagonists, several opioid agonists (morphine, fentanyl, buprenorphine, and methadone) lacked detectable effects on ERES levels...Me-Ntx failed to significantly increase ERES levels, suggesting that antagonists must enter the cell to serve as pharmacological chaperones, consistent with our proposed inside-out pharmacology mechanism. The possibility that antagonists induce supersensitivity by pharmacologically chaperoning opioid receptors could suggest innovative approaches for opioid abuse disorder.
- |||||||||| Zubsolv (buprenorphine/naloxone sublingual tablet) / Orexo, Mundipharma
Enrollment closed, Trial completion date, Trial primary completion date: Assessing the Safety of Buprenorphine in People With Sickle Cell Disease (clinicaltrials.gov) - Jul 8, 2020
P2, N=20, Active, not recruiting,
The possibility that antagonists induce supersensitivity by pharmacologically chaperoning opioid receptors could suggest innovative approaches for opioid abuse disorder. Enrolling by invitation --> Active, not recruiting | Trial completion date: Jun 2020 --> Sep 2020 | Trial primary completion date: Jun 2020 --> Sep 2019
- |||||||||| Zubsolv (buprenorphine/naloxone sublingual tablet) / Orexo, Mundipharma, Suboxone (buprenorphine/naloxone sublingual film) / Indivior
Journal: Treatment of acute naloxone-precipitated opioid withdrawal with buprenorphine. (Pubmed Central) - Jun 19, 2020
This case highlights the potential of buprenorphine as a treatment modality for acute naloxone-precipitated opioid withdrawal. Due to the risks of worsening or sustained buprenorphine-precipitated opioid withdrawal, further research is warranted to identify patients who may benefit from this therapy.
- |||||||||| Zubsolv (buprenorphine/naloxone sublingual tablet) / Orexo, Mundipharma, Suboxone (buprenorphine/naloxone sublingual film) / Indivior
Biomarker, Clinical, Journal: Pharmacogenomics and OUD: Clinical Decision Support in an African American Cohort. (Pubmed Central) - Jun 18, 2020
Kaplan-Meier survival analyses were used to assess time to first withdrawal. Our research suggests that patients with at least one copy of the CYP3A4*1B allele exhibit an accelerated rate of metabolism compared to the wild-type allele CYP3A4*1.
- |||||||||| Zubsolv (buprenorphine/naloxone sublingual tablet) / Orexo, Mundipharma, Suboxone (buprenorphine/naloxone sublingual film) / Indivior, methadone / Generic mfg.
Journal: Challenges in maintaining treatment services for people who use drugs during the COVID-19 pandemic. (Pubmed Central) - May 12, 2020
The use of monthly depot buprenorphine as well as moving from a framework of supervised dosing will be required for patients on sublingual buprenorphine and methadone...Opiate users may misinterpret SARS-CoV2 symptoms as opiate withdrawal and manage this by using opioids. Ensuring people who use drugs have access to drug treatment as well as access to screening and testing for SARS-CoV2 where this is indicated is important.
- |||||||||| Zubsolv (buprenorphine/naloxone sublingual tablet) / Orexo, Mundipharma, Suboxone (buprenorphine/naloxone sublingual film) / Indivior, quetiapine / Generic mfg.
Journal: 171 Buprenorphine - A Treatment for Psychic Pain and Suicidal Ideation? (Pubmed Central) - Apr 28, 2020
He also endorsed chronic pain and hopelessness.Upon transfer to the behavioral health unit, his symptoms persisted, despite trials of quetiapine, mirtazapine, methadone, oxycodone and prazosin...We speculate that BPN's pharmacokinetic properties terminate the cycle of short-term opioid-induced analgesia and euphoria with opioid withdrawal-induced hyperalgesia and dysphoria. This results in a steady treatment of pain, as well as maintaining the dopaminergic system, symptomatically translating to mood stabilization and annulling suicidal ideation.
- |||||||||| Sublocade (buprenorphine once-monthly depot) / Indivior
Enrollment open: XRB vs. SLB in Jail and at Re-entry: Pilot, Proof of Concept (clinicaltrials.gov) - Apr 24, 2020
P4, N=50, Recruiting,
This results in a steady treatment of pain, as well as maintaining the dopaminergic system, symptomatically translating to mood stabilization and annulling suicidal ideation. Not yet recruiting --> Recruiting
- |||||||||| Zubsolv (buprenorphine/naloxone sublingual tablet) / Orexo, Mundipharma, Suboxone (buprenorphine/naloxone sublingual film) / Indivior
Clinical, Review, Journal: The perioperative patient on buprenorphine: a systematic review of perioperative management strategies and patient outcomes. (Pubmed Central) - Apr 15, 2020
In patients with significant potential for relapse, such as those with a recent history of OUD, the discontinuation of buprenorphine should have a strong rationale supported by patient and surgical preferences. Future studies require standardized reporting of median doses, details on the route of delivery, dosing schedules and any dosing changes, and rates of addiction relapse, including long-term morbidity and mortality where possible.
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